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Sponsors and Collaborators: |
Weill Medical College of Cornell University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00437034 |
RATIONALE: VEGF Trap may be able to carry cancer-killing substances directly to multiple myeloma cells. It may also stop the growth of multiple myeloma by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with stage II or stage III multiple myeloma that has relapsed or not responded to previous treatment.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: aflibercept Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of VEGF Trap (NSC 724770) for the Treatment of Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for biological markers and angiogenic profiles via immunoenzyme techniques and flow cytometry. Biomarkers may include vascular endothelial growth factor (VEGF) subtypes, platelet-derived growth factor, fibroblast growth factor, thrombopoietin, stromal-cell-derived factor, interleukin (IL)-6, IL-7, and VEGF receptor 1.
After completion of study treatment, patients are followed for 60 days and then periodically thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed multiple myeloma
Measurable disease, defined by ≥ 1 of the following criteria:
Must have received ≥ 2 prior therapies* for multiple myeloma that meet the following criteria:
PATIENT CHARACTERISTICS:
No albuminuria only
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent full-dose anticoagulants (e.g., warfarin) with PT or INR >1.5 allowed provided the following criteria are met:
United States, New York | |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Recruiting |
Manhasset, New York, United States, 11030 | |
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center 516-734-8900 | |
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
Contact: Janice L. Gabrilove, MD 212-241-9650 janice.gabrilove@mssm.edu | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 |
Study Chair: | Ruben Niesvizky, MD | Weill Medical College of Cornell University |
Study ID Numbers: | CDR0000530040, NYWCCC-0608008688 |
Study First Received: | February 15, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00437034 |
Health Authority: | Unspecified |
stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma |
Immunoproliferative Disorders Hemorrhagic Disorders Multiple myeloma Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders |
Vascular Diseases Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Cardiovascular Diseases |